Peripheral Arterial DiseaseINITIATENCT04042311
High Intensity Interval Training In pATiEnts With Intermittent Claudication
A study testing High-intensity interval training in people with Peripheral Arterial Disease and Intermittent Claudication, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This INITIATE study evaluates the use of high-intensity interval training as a treatment modality for patients with intermittent claudication - an ambulatory leg pain caused by narrowed arteries that supply the lower limbs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Intermittent Claudication
- What is being tested?
- High-intensity interval training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jun 2018to 4 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged >18 years
- Ankle-brachial pressure index (ABPI) <0.9 at rest or a systolic pressure drop of ≥20mmHg at the ankle after exercise testing
- Ability to walk unaided
- English speaking and able to comply with exercise instructions
- Aged >18 years
- ABPI <0.9 at rest or a systolic pressure drop of ≥20mmHg at the ankle after exercise testing
- Ability to walk unaided
- English speaking and able to comply with exercise instructions
Who cannot join
- Unable to provide informed consent
- Critical limb threatening ischaemia / rest pain / tissue loss
- Active cancer treatment
- Significant comorbidities precluding safe participation in exercise testing and / or training according to the American College of Sports Medicine (ACSM) guidelines (28)
- Resting/uncontrolled tachycardia (>100 beats per minute [bpm]) and/or resting/uncontrolled hypertension (systolic blood pressure >180 millimetres of mercury [mmHg] or diastolic blood pressure >100mmHg)
- Symptomatic hypotension
Show all 20Show fewer
- Additional exclusion criteria:
- Following baseline cardiopulmonary exercise test (CPET), patients will be withdrawn and prevented from continuing their involvement in the study if there is any evidence of:
- Exercise-induced myocardial ischaemia or significant haemodynamic compromise (manifesting as anginal symptoms, significant ECG changes or an abnormal blood pressure response).
- An inability to complete a maximal effort CPET
- Workstream 2:
- Unable to provide informed consent
- Critical limb threatening ischaemia / rest pain / tissue loss
- Active cancer treatment
- Significant comorbidities precluding safe participation in exercise testing and / or training according to the American College of Sports Medicine (ACSM) guidelines (28)
- Resting/uncontrolled tachycardia (>100bpm) and/or resting/uncontrolled hypertension (systolic blood pressure >180mmHg or diastolic blood pressure >100mmHg)
- Symptomatic hypotension
- Additional exclusion criteria:
- Following baseline CPET, patients will be withdrawn and prevented from continuing their involvement in the study if there is any evidence of:
- ● Exercise-induced myocardial ischaemia or significant haemodynamic compromise (manifesting as anginal symptoms, significant ECG changes or an abnormal blood pressure response).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Academic Vascular Surgical Unit, Vascular Dept. 1st Floor Tower Block
Hull, HU3 2JZ
About this study
Official title: High Intensity Interval Training In pATiEnts With Intermittent Claudication (INITIATE): a Proof-of-concept Prospective Cohort Study to Assess Acceptability, Feasibility and Potential Clinical Efficacy
This INITIATE study evaluates the use of high-intensity interval training as a treatment modality for patients with intermittent claudication - an ambulatory leg pain caused by narrowed arteries that supply the lower limbs.
It is an observational cohort study considering high-intensity interval training (HIIT) as a treatment for intermittent claudication, consisting of two workstreams. Workstream 1: an initial observational cohort study to consider the feasibility of the intervention and exclusion criteria. Workstream 2: a proof of concept study utilising the altered intervention and exclusion criteria following recommendations highlighted during workstream 1.
Read the detailed description
Patients with peripheral vascular disease (PVD) may develop a reproducible pain in their legs when they walk, which usually subsides with rest. This is known as intermittent claudication (IC) and is caused by a reduced blood supply to the legs as a result of narrowed or hardened arteries that supply the lower limbs. This ambulatory pain impedes on activities of daily living, functional capacity and quality of life.
National Institute for Health and Care Excellence (NICE) clinical guidance recommends a 12-week supervised exercise programme as first-line treatment for IC, whereby patients are encouraged to walk to the point of maximal pain. Robust clinical trials have demonstrated that supervised exercise programmes are efficacious for improving both pain-free and maximal walking distances, whilst also potentially improving quality of life.
Despite this, supervised exercise programmes are vastly under-utilised and not always available to consultant vascular surgeons. This means that further programmes need to be developed in order to provide a range of options to patients to improve uptake and adherence rates. One such programme is a 6-week high-intensity interval training programme.
An initial observational cohort study of the 6 week HIIT programme will be conducted to determine to determine the feasibility of the intervention and inclusion criteria. The results from this will be used to make any necessary changes to the HIIT intervention before moving into a proof of concept study, considering the utility, safety, acceptability and potential clinical efficacy of this programme.
- Being tested
- High-intensity interval training
- Keywords
- Exercise, High-intensity interval training, interval training
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval trainingOther
a high-intensity interval training programme completed 3 times a week for 6 weeks using a stationary Wattbike.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity interval training (workstream 1) | Experimental | High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate. Receives: Other: High-intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability Test - Related Withdrawals
Defined by examining the number of withdrawals related to the intervention or study procedures (i.e. patients unable to tolerate).
Measured: From the first to last exercise session, i.e. from week 0 to week 6.
Feasibility Test
Feasibility measures included the number of patients screened vs. the number eligible, the number of patients eligible vs. the number recruited and the number recruited vs. the number completed.
Measured: From study opening to completion/withdrawal of the last patient
Tolerability Test - Achieving the Required Intensity
Considers the patients ability to achieve and maintain exercise at the appropriate intensity for the duration of each session
Measured: From the first to last exercise session, i.e. from week 0 to week 6.
Tolerability Test - Number of Sessions Completed
Considers the number of sessions completed compared to the theoretical number.
Measured: From the first to last exercise session, i.e. from week 0 to week 6.
Tolerability Test - Number of HIIT Intervals Completed
Considers the number of HIIT intervals completed compared to the theoretical number.
Measured: From the first to last exercise session, i.e. from week 0 to week 6.
Secondary outcomes (12)
Safety Events Recorded
Defined as the occurrence of any adverse or serious adverse events related to the intervention.
Measured: From enrolment to completion of 12-week follow-up
Acceptability Testing
An evaluation of the acceptability of the exercise intervention assessed by patient feedback, using semi-structured interviews.
Measured: post-intervention follow-up, i.e. week 6.
Maximum Walking Distance
assessment of the distance that the patient can currently walk before having to stop due to claudication pain.
Measured: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Peak Oxygen Uptake
Peak oxygen uptake assessed via cardiopulmonary exercise testing
Measured: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Quality of Life Questionnaire Short-form-36 (SF-36)
Patient reported quality of life using the SF-36 SF-36 is a 36-Item Short Form Health Survey questionnaire. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
Measured: Baseline and post-intervention (week 6)
Vascular Quality of Life Questionnaire - (VascuQol)
VascuQoL includes 25 items subdivided into 5 domains and a sum score is also calculated by dividing the total score by 25.
Each domain and the total score range from 1 to 7 with 1 representing the worst score and 7 the best.
Measured: Baseline and post-intervention (week 6) follow-up
Ankle-Brachial Pressure Index
The index or ratio of the pressure in the ankle compared with the arm.
Measured: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Peak Power Output
Peak power output assessed via CPET
Measured: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Pain-free Walking Distance
assessment of the distance that the patient can currently walk before experiencing claudication pain.
Measured: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Ventilatory Anaerobic Threshold (VAT)
Ventilatory anaerobic threshold assessed via cardiopulmonary exercise testing
Measured: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Quality of Life Questionnaire Short-form-36 (SF-36)
Patient reported quality of life using the SF-36 SF-36 is a 36-Item Short Form Health Survey questionnaire. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
Measured: 4 weeks (week 10) and 12 weeks (week 18) post-intervention
Vascular Quality of Life Questionnaire - (VascuQol)
VascuQoL includes 25 items subdivided into 5 domains and a sum score is also calculated by dividing the total score by 25.
Each domain and the total score range from 1 to 7 with 1 representing the worst score and 7 the best.
Measured: 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start15 Jun 2018
- Primary completion4 Apr 2022
- Study completion4 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Workstream 1: An initial single group cohort of 30 patients will be recruited and analysed to refine/alter the intervention and exclusion criteria based on its feasibility. Workstream 2: This altered intervention and inclusion criteria will be considered in a further proof of concept study which will be multi-centre aiming to recruit a further x40 patients.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Hull
- Responsible party
- Sponsor
- Investigators
- Sean Pymer, MSc, Principal investigator, Academic Vascular Surgical Unit, Hull York Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042311
- Sponsor's protocol ID
- R2219
- Acronym
- INITIATE
- Status last verified
- Sep 2024
- First submitted
- 11 Jul 2019
- Last updated
- 14 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pymer S, Harwood AE, Ibeggazene S, McGregor G, Huang C, Nicholls AR, Ingle L, Long J, Rooms M, Chetter IC, Twiddy M. High INtensity Interval Training in pATiEnts with Intermittent Claudication: A Qualitative Acceptability Study. Ann Vasc Surg. 2024 May;102:17-24. doi: 10.1016/j.avsg.2023.11.043. Epub 2024 Jan 30.
PubMed 38301846Pymer S, Harwood AE, Prosser J, Waddell A, Rhavindhran B, Ibeggazene S, McGregor G, Huang C, Twiddy M, Nicholls AR, Ingle L, Carroll S, He H, Long J, Rooms M, Chetter IC. High-intensity interval training in patients with intermittent claudication. J Vasc Surg. 2023 Oct;78(4):1048-1056.e4. doi: 10.1016/j.jvs.2023.05.045. Epub 2023 Jun 16.
PubMed 37330704Pymer S, Ibeggazene S, Palmer J, Smith GE, Harwood AE, Carroll S, Ingle L, Chetter IC. Considering the Feasibility, Tolerability, and Safety of High-Intensity Interval Training as a Novel Treatment for Patients With Intermittent Claudication. J Cardiopulm Rehabil Prev. 2021 May 1;41(3):188-193. doi: 10.1097/HCR.0000000000000551.
PubMed 33186201Pymer S, Harwood A, Ibeggazene S, McGregor G, Huang C, Twiddy M, Nicholls AR, Ingle L, Carroll S, Long J, Rooms M, Chetter IC; INITIATE investigator group. High INtensity Interval Training In pATiEnts with intermittent claudication (INITIATE): protocol for a multicentre, proof-of-concept, prospective interventional study. BMJ Open. 2020 Jul 6;10(7):e038825. doi: 10.1136/bmjopen-2020-038825.
PubMed 32636290
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Interval Training In pATiEnts With Intermittent Claudication (INITIATE): a Proof-of-concept Prospective Cohort Study to Assess Acceptability, Feasibility and Potential Clinical Efficacy
- ClinicalTrials.gov ID
- NCT04042311
- Acronym / sponsor ID
- INITIATE / R2219
- Keywords
- Exercise, High-intensity interval training, interval training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Collaborators
- University of Hull
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 4 Jul 2022 (actual)
- First posted
- 1 Aug 2019 (actual)
- Results
- Posted 14 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This INITIATE study evaluates the use of high-intensity interval training as a treatment modality for patients with intermittent claudication - an ambulatory leg pain caused by narrowed arteries that supply the lower limbs.
It is an observational cohort study considering high-intensity interval training (HIIT) as a treatment for intermittent claudication, consisting of two workstreams. Workstream 1: an initial observational cohort study to consider the feasibility of the intervention and exclusion criteria. Workstream 2: a proof of concept study utilising the altered intervention and exclusion criteria following recommendations highlighted during workstream 1.
Detailed description
Patients with peripheral vascular disease (PVD) may develop a reproducible pain in their legs when they walk, which usually subsides with rest. This is known as intermittent claudication (IC) and is caused by a reduced blood supply to the legs as a result of narrowed or hardened arteries that supply the lower limbs. This ambulatory pain impedes on activities of daily living, functional capacity and quality of life.
National Institute for Health and Care Excellence (NICE) clinical guidance recommends a 12-week supervised exercise programme as first-line treatment for IC, whereby patients are encouraged to walk to the point of maximal pain. Robust clinical trials have demonstrated that supervised exercise programmes are efficacious for improving both pain-free and maximal walking distances, whilst also potentially improving quality of life.
Despite this, supervised exercise programmes are vastly under-utilised and not always available to consultant vascular surgeons. This means that further programmes need to be developed in order to provide a range of options to patients to improve uptake and adherence rates. One such programme is a 6-week high-intensity interval training programme.
An initial observational cohort study of the 6 week HIIT programme will be conducted to determine to determine the feasibility of the intervention and inclusion criteria. The results from this will be used to make any necessary changes to the HIIT intervention before moving into a proof of concept study, considering the utility, safety, acceptability and potential clinical efficacy of this programme.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Workstream 1: An initial single group cohort of 30 patients will be recruited and analysed to refine/alter the intervention and exclusion criteria based on its feasibility. Workstream 2: This altered intervention and inclusion criteria will be considered in a further proof of concept study which will be multi-centre aiming to recruit a further x40 patients.
| Arm | Type | Receives |
|---|---|---|
| High-Intensity interval training (workstream 1) | Experimental | Other: High-intensity interval trainingHigh-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged >18 years
- Ankle-brachial pressure index (ABPI) <0.9 at rest or a systolic pressure drop of ≥20mmHg at the ankle after exercise testing
- Ability to walk unaided
- English speaking and able to comply with exercise instructions
- Aged >18 years
Key exclusion criteria (20 listed)
- Unable to provide informed consent
- Critical limb threatening ischaemia / rest pain / tissue loss
- Active cancer treatment
- Significant comorbidities precluding safe participation in exercise testing and / or training according to the American College of Sports Medicine (ACSM) guidelines (28)
- Resting/uncontrolled tachycardia (>100 beats per minute [bpm]) and/or resting/uncontrolled hypertension (systolic blood pressure >180 millimetres of mercury [mmHg] or diastolic blood pressure >100mmHg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity interval traininga high-intensity interval training programme completed 3 times a week for 6 weeks using a stationary Wattbike. | Other | High-Intensity interval training (workstream 1) |
Primary outcome
Tolerability Test - Related Withdrawals
Time frame: From the first to last exercise session, i.e. from week 0 to week 6.
Defined by examining the number of withdrawals related to the intervention or study procedures (i.e. patients unable to tolerate).
Feasibility Test
Time frame: From study opening to completion/withdrawal of the last patient
Feasibility measures included the number of patients screened vs. the number eligible, the number of patients eligible vs. the number recruited and the number recruited vs. the number completed.
Tolerability Test - Achieving the Required Intensity
Time frame: From the first to last exercise session, i.e. from week 0 to week 6.
Considers the patients ability to achieve and maintain exercise at the appropriate intensity for the duration of each session
Tolerability Test - Number of Sessions Completed
Time frame: From the first to last exercise session, i.e. from week 0 to week 6.
Considers the number of sessions completed compared to the theoretical number.
Tolerability Test - Number of HIIT Intervals Completed
Time frame: From the first to last exercise session, i.e. from week 0 to week 6.
Considers the number of HIIT intervals completed compared to the theoretical number.
12 secondary outcomes
Safety Events Recorded
Time frame: From enrolment to completion of 12-week follow-up
Acceptability Testing
Time frame: post-intervention follow-up, i.e. week 6.
Maximum Walking Distance
Time frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Peak Oxygen Uptake
Time frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Quality of Life Questionnaire Short-form-36 (SF-36)
Time frame: Baseline and post-intervention (week 6)
Vascular Quality of Life Questionnaire - (VascuQol)
Time frame: Baseline and post-intervention (week 6) follow-up
Ankle-Brachial Pressure Index
Time frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Peak Power Output
Time frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Pain-free Walking Distance
Time frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Ventilatory Anaerobic Threshold (VAT)
Time frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Quality of Life Questionnaire Short-form-36 (SF-36)
Time frame: 4 weeks (week 10) and 12 weeks (week 18) post-intervention
Vascular Quality of Life Questionnaire - (VascuQol)
Time frame: 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38301846Pymer S, Harwood AE, Ibeggazene S, McGregor G, Huang C, Nicholls AR, Ingle L, Long J, Rooms M, Chetter IC, Twiddy M. High INtensity Interval Training in pATiEnts with Intermittent Claudication: A Qualitative Acceptability Study. Ann Vasc Surg. 2024 May;102:17-24. doi: 10.1016/j.avsg.2023.11.043. Epub 2024 Jan 30.
- Results publication: PubMed 37330704Pymer S, Harwood AE, Prosser J, Waddell A, Rhavindhran B, Ibeggazene S, McGregor G, Huang C, Twiddy M, Nicholls AR, Ingle L, Carroll S, He H, Long J, Rooms M, Chetter IC. High-intensity interval training in patients with intermittent claudication. J Vasc Surg. 2023 Oct;78(4):1048-1056.e4. doi: 10.1016/j.jvs.2023.05.045. Epub 2023 Jun 16.
- Derived from this study: PubMed 33186201Pymer S, Ibeggazene S, Palmer J, Smith GE, Harwood AE, Carroll S, Ingle L, Chetter IC. Considering the Feasibility, Tolerability, and Safety of High-Intensity Interval Training as a Novel Treatment for Patients With Intermittent Claudication. J Cardiopulm Rehabil Prev. 2021 May 1;41(3):188-193. doi: 10.1097/HCR.0000000000000551.
- Derived from this study: PubMed 32636290Pymer S, Harwood A, Ibeggazene S, McGregor G, Huang C, Twiddy M, Nicholls AR, Ingle L, Carroll S, Long J, Rooms M, Chetter IC; INITIATE investigator group. High INtensity Interval Training In pATiEnts with intermittent claudication (INITIATE): protocol for a multicentre, proof-of-concept, prospective interventional study. BMJ Open. 2020 Jul 6;10(7):e038825. doi: 10.1136/bmjopen-2020-038825.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Pymer, MSc principal investigator
Academic Vascular Surgical Unit, Hull York Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training in people with Peripheral Arterial Disease and Intermittent Claudication, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability Test - Related Withdrawals (time frame: From the first to last exercise session, i.e. from week 0 to week 6.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04042311, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.